Clinical Evaluation of Lutetium-177 Labeled BQ7876 for Targeting of Prostate-Specific Membrane Antigen
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- [177Lu]Lu-BQ7876 blood сlearance
研究概览
简要总结
The study should evaluate the biological distribution of [177Lu]Lu-BQ7876 in patients with prostate cancer.
The objective are:
- To evaluate the content of [177Lu]Lu-BQ7876 in the blood of patients with prostate cancer at different time points after a single intravenous administration.
- To assess the distribution of [177Lu]Lu-BQ7876 in normal tissues and tumors at different time points.
- To evaluate dosimetry of [177Lu]Lu-BQ7876.
- To study the safety and tolerability of the drug [177Lu]Lu-BQ7876 after a single injection.
详细描述
The overall goal is to study the effectiveness of prostate-specific membrane antigen targeting using Lutetium-177 - labeled BQ7876.
Phase I of the study:
Biodistribution, dosimetry, safety and tolerability of [177Lu]Lu-BQ7876 in patients with prostate cancer.
The main objectives of the study:
- To evaluate the content of [177Lu]Lu-BQ7876 in the blood of patients with prostate cancer at different time points after a single intravenous administration.
- To evaluate the distribution of [177Lu]Lu-BQ7876 in normal tissues and tumors in patients with prostate cancer at different time points after a single intravenous administration.
- To evaluate dosimetry of [177Lu]Lu-BQ7876 based on the pharmacokinetic parameters of the drug after a single intravenous administration.
- To study the safety of use and tolerability of the drug [177Lu]Lu-BQ7876 after a single intravenous administration in a diagnostic dosage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject is > 18 years of age
- •Clinical and radiological diagnosis of prostate cancer with histological verification.
- •White blood cell count: > 2.0 x 10^9/L
- •Haemoglobin: > 80 g/L
- •Platelets: > 50.0 x 10^9/L
- •Bilirubin =< 2.0 times Upper Limit of Normal
- •Serum creatinine: Within Normal Limits
- •Blood glucose level not more than 5.9 mmol/L
- •Subject is capable to undergo the diagnostic investigations to be performed in the study
- •Informed consent
排除标准
- •Active current autoimmune disease or history of autoimmune disease
- •Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening)
- •Known HIV positive or chronically active hepatitis B or C
- •Administration of other investigational medicinal product within 30 days of screening
- •Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's
研究组 & 干预措施
Prostate cancer
One single intravenous injection of [177Lu]Lu-BQ7876
干预措施: One single intravenous injection of [177Lu]Lu-BQ7876 (Drug)
结局指标
主要结局
[177Lu]Lu-BQ7876 blood сlearance
时间窗: 48 hours
Measurement of \[177Lu\]Lu-BQ7876 activity in patient blood samples at various time points: after 5, 10, 20, 40, 60 and 90 minutes, 2, 3, 24, 48 hours.
Gamma camera-based whole-body [177Lu]Lu-BQ7876
时间窗: 120 hours
Whole-body \[177Lu\]Lu-BQ7876 uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical at 1, 4, 24, 48, 72, 120 hours after single injection.
SPECT/CT-based [177Lu]Lu-BQ7876 uptake in tumor lesions (SUVmean)
时间窗: 120 hours
\[177Lu\]Lu-BQ7876 uptake (SUVmean) with tumor lesions will be assessed using single-photon emission computed tomography and measured in SUVmean after 4, 48, 72 and 120 hours after single injection of radiopharmaceutical.
次要结局
- Percent of cases with abnormal findings relative to baseline [Safety and Tolerability](48 hours)
- Percent of participants with abnormal laboratory values that are related to [177Lu]Lu-BQ7876 injection [Safety and Tolerability](48 hours)
- Percent of participants with adverse events that are related to [177Lu]Lu-BQ7876 injection [Safety and Tolerability](48 hours)
- Percent of participants requiring administration of medication due to side effects that are related to [177Lu]Lu-BQ7876 injection [Safety and Tolerability](48 hours)